Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ecarf Institute GmbH | OTHER |
| Bencard Allergie GmbH | OTHER |
Not provided
Not provided
Not provided
Not provided
The aim of the study is to investigate the antigen-unspecific effect of a 3 months supplementation with a food for special medical purposes (FSMP) in form of a lozenge containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in patients with allergic rhinoconjunctivitis caused by cat (hair/dander) and the associated symptoms (symptom type and severity) during exposure to cat allergen in an Allergen Exposure Chamber (AEC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| holoBLG | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| holoBLG | Dietary Supplement | holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, loaded with ligands (vitamin A, zinc and polyphenol-iron complexes) |
| Measure | Description | Time Frame |
|---|---|---|
| TSS | Total Symptom Score in response to cat exposure in an AEC at baseline versus final AEC exposure. The TSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose), 4 eye symptoms (itchy eyes, watery eyes, gritty feeling, eye reddening), 4 bronchial symptoms (wheezing, cough, breathlessness, rhonchus), and 2 other symptoms (itchy palate, and itchy skin) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TSS of 42. | After 120 minutes of allergen challenge |
| Measure | Description | Time Frame |
|---|---|---|
| TNSS | The Total Nasal Symptom Score (TNSS) is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TNSS of 12. | Up to 120 minutes following allergen challenge |
| TESS |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karl-Christian Bergmann, Prof. Dr. med. | Institute of Allergology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECARF Institute GmbH | Berlin | 10115 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37488734 | Result | Bergmann KC, Raab J, Graessel A, Zwingers T, Becker S, Kugler S, Zuberbier T, Roth-Walter F, Kramer MF, Jensen-Jarolim E. The holo beta-lactoglobulin lozenge reduces symptoms in cat allergy-Evaluation in an allergen exposure chamber and by titrated nasal allergen challenge. Clin Transl Allergy. 2023 Jul;13(7):e12274. doi: 10.1002/clt2.12274. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Total Eye Symptom Score (TESS) is the sum of 4 eye symptoms (itchy eyes, watery eyes, gritty feeling, eye reddening) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TESS of 12. |
| Up to 120 minutes following allergen challenge |
| TBSS | The Total Bronchial Symptom Score (TBSS) is the sum of 4 bronchial symptoms (wheezing, cough, breathlessness, rhonchus) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TBSS of 12. | Up to 120 minutes following allergen challenge |
| VAS | Visual Analogue Scale: Before, every 30 minutes during and after each exposure patients grade the question on their well-being by putting a vertical line on a 10 cm line representing severity from 0 cm "very good" to 10 cm "very bad". | Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes |
| PNIF | PNIF (peak nasal inspiration flow) liter/minute. | Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes |
| PEF | PEF (peak expiratory flow) liter/minute | Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes |
| FEV1 | Forced expiratory volume in 1 second, before and after the exposure | Recorded at time zero (0) and 120 minutes |
| FEV1/FVC | Forced expiratory volume in 1 second/forced vital capacity ratio, before and after the exposure. | Recorded at time zero (0) and 120 minutes |
| Adverse events with regards to the allergen exposure | Number of events and number of patients recording late-phase reactions and/or adverse events with regards to the allergen exposure | up to 24 hours after AEC exposure |
| NPT | Changes in Nasal Provocation Test before and after intervention period | up to 3 months following first AEC |
| TOSS | The Total Other Symptom Score (TBSS) is the sum of 2 additional symptoms (itchy palate, itchy skin) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TOSS of 6. | Up to 120 minutes following allergen challenge |